PNN

Orthodontic Software

Product code

PNN

Device name

Orthodontic Software

Device class

Class 2

21 CFR

21 CFR 872.5470

Medical specialty

Dental

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (last 3 years)

11

Summaries archived here

10 (direct download)

510(k) clearances (all years, FDA)

34 (all years; only the last 3 years are listed here)

FDA classification definition

The device is software that is to be used for the diagnosis and treatment planning of orthodontic patients and conditions. It may include orthodontic output devices used for the treatment of orthodontics. The device is intended for prescription use only.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (11)

Last three years. Most recent: 2026-05-08.

10 summaries are archived here for direct download.